Tribenzor

INDICATIONS

Tribenzor (olmesartan
medoxomil, amlodipine, hydrochlorothiazide) is indicated for the treatment of
hypertension, to lower blood pressure. Lowering blood pressure reduces the risk
of fatal and nonfatal cardiovascular events, primarily strokes and myocardial
infarctions. These benefits have been seen in controlled trials of
antihypertensive drugs from a wide variety of pharmacologic classes including
the class to which this drug principally belongs. There are no controlled
trials demonstrating risk reduction with Tribenzor.

Control of high blood pressure
should be part of comprehensive cardiovascular risk management, including, as
appropriate, lipid control, diabetes management, antithrombotic therapy,
smoking cessation, exercise, and limited sodium intake. Many patients will
require more than one drug to achieve blood pressure goals. For specific advice
on goals and management, see published guidelines, such as those of the
National High Blood Pressure Education Program's Joint National Committee on
Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive
drugs, from a variety of pharmacologic classes and with different mechanisms of
action, have been shown in randomized controlled trials to reduce cardiovascular
morbidity and mortality, and it can be concluded that it is blood pressure
reduction, and not some other pharmacologic property of the drugs, that is
largely responsible for those benefits. The largest and most consistent
cardiovascular outcome benefit has been a reduction in the risk of stroke, but
reductions in myocardial infarction and cardiovascular mortality also have been
seen regularly.

Elevated systolic or diastolic
pressure causes increased cardiovascular risk, and the absolute risk increase
per mmHg is greater at higher blood pressures, so that even modest reductions
of severe hypertension can provide substantial benefit. Relative risk reduction
from blood pressure reduction is similar across populations with varying
absolute risk, so the absolute benefit is greater in patients who are at higher
risk independent of their hypertension (for example, patients with diabetes or
hyperlipidemia), and such patients would be expected to benefit from more
aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure
effects (as monotherapy) in black patients, and many antihypertensive drugs
have additional approved indications and effects (e.g., on angina, heart
failure, or diabetic kidney disease). These considerations may guide selection
of therapy.

This fixed combination drug is not indicated for the
initial therapy of hypertension [see DOSAGE AND ADMINISTRATION].

DOSAGE AND ADMINISTRATION

General Considerations

Dose once daily.

Dosage may be increased after 2 weeks. The full blood
pressure lowering effects are attained within 2 weeks after a change in dose.
The maximum recommended dose of Tribenzor is 40/10/25 mg. Tribenzor may be
taken with or without food.

Tribenzor may be administered with other antihypertensive
agents.

Renal Impairment

The usual regimens of therapy with Tribenzor may be
followed if the patient's creatinine clearance is > 30 mL/min. In patients
with more severe renal impairment, loop diuretics are preferred to thiazides,
so avoid use of Tribenzor [see WARNINGS AND PRECAUTIONS].

Elderly

Patients ≥ 75 years of age should start amlodipine
at 2.5 mg, which is not available with Tribenzor.

Hepatic Impairment

Patients with severe hepatic impairment should start
amlodipine at 2.5 mg, which is not available with Tribenzor [see WARNINGS
AND PRECAUTIONS].

Replacement Therapy

Tribenzor may be substituted for its individually
titrated components.

Add-on/Switch Therapy

Tribenzor may be used to provide additional blood
pressure lowering for patients not adequately controlled on maximally
tolerated, labeled, or usual doses of any two of the following antihypertensive
classes: angiotensin receptor blockers (ARB), calcium channel blockers (CCB),
and diuretics.

A patient who experiences dose-limiting adverse reactions
to an individual component while on any dual combination of the components of
Tribenzor may be switched to Tribenzor containing a lower dose of that
component to achieve similar blood pressure reductions.

Storage And Handling

Tribenzor tablets contain
olmesartan medoxomil, amlodipine besylate at a dose equivalent to 5 or 10 mg
amlodipine, and hydrochlorothiazide in the strengths described below.

Tribenzor tablets are differentiated by tablet color/size
and are debossed with an individual product tablet code on one side. Tribenzor
tablets are supplied for oral administration in the following strength and
package configurations: